TCM Clinical Practice Rehabilitation of Post-stroke Spasticity

Stroke Clinical Trial

Official title:

Traditional Chinese Medicine Clinical Practice Rehabilitation of Post-stroke Spasticity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03054974
• Other study ID #: 2013BAI10B04
• Status: Recruiting
• Phase: N/A
• First received: November 20, 2016
• Last updated: February 15, 2017
• Start date: January 2013
• Est. completion date: December 2018

Study information

• Verified date: February 2017
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: li jianan, Doctor
• Phone: +862583318752
• Email: lijianan[@]carm.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness,safety and Input-output ratio of chinese traditional treatment in spasm after stroke,both in massage and herbal medicine bathing.

Description:

A Muti-center randomized controlled study with large samples to observe improvement of motor function,severity of spasm,ADL(activity of daily lives),by standardized protocols of TCM techniques(massage and herbal bathing) combined with conventional rehabilitation on spasm after stroke in 1 month.Modified Ashworth scale,Fugl-Meyer Index and Modified barthel Index were used for spasm,motor function and ADL.And also the follow up research within 3 months and 6 months focus on the efficacy duration of TCM on spasm.Try to find suitable timing for intervention on spasm by CTM(Massage and herbal medicine bathing)and the connection between spasm severity and treatment efficacy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1208
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• According to the diagnostic criteria of stroke and diagnosed by CT or MRI

• Patient must be between the ages of 18 and 85 years.

• All patients were examined at least 1 month after stroke and less than 12 months.

• At least a set of spasmous muscles' level =1+ of dysfunctional extremities (modified Ashworth scale)

• Body movement function decreased significantly.

• The doses and kinds of anticonvulsant drugs should be used stable for more than 1 month if they are used

• Patient must understand and be willing, able and likely to comply with all study procedures.

• Patient must be able to give voluntary written informed consent.

Exclusion Criteria:

• Significant cognitive defects(MMSE<16),unable to finish the Fugl-Meyer scale,etc..

• Other significant limb diseases such as fracture, severe arthritis,amputation

• Joint contracture formation

• Patients with significant pain and swelling suffering from complex regional syndrome after acute stroke

• Accept botulinum toxin or alcohol nerve block 3 months prior to the start of the experiment

• Patients need nerve block at any point of time during the whole experiment procedure.

• Serious cardiac,hepatic or renal insufficiency and patients with shock.

• Limb skin of patients who need medicated is visible wound.

• Patients with cancer or pregnancy

• Patients who participate in other clinical studies within 6 months

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Modern rehabilitation treatment
PT 1 hour per day and OT 30min per day
• Modern rehabilitation &TCM
Traditional Chinese Medicine, including massage and medicated bath
• modern rehabilitation &Baimai Ruangao
modern rehabilitation treatment with Baimai Ruangao and massage
• modern rehabilitation &Tibetan medicine
modern rehabilitation treatment and Tibetan medicine(medicated bath with wuweiganlu and rub with baimairuangao)

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Barthel Index		6 months
Primary	Modified Ashworth Scale	the common used clinical measurement to assess the levels of limb spasticity	6 months
Secondary	Fugl-Meyer Moter Assessment		6 months